GLYC - Earnings call transcript Q1 2022

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Operator

Good morning, and thank you for joining the GlycoMimetics Call. [Operator Instructions] I’d now like to turn the call over to Shari Annes of Investor Relations Group of GlycoMimetics. Please go ahead.

Shari Annes

Good morning. Today, we will review our accomplishments and financial results for the quarter ended March 31, 2022. issued www.glycomimetics.com is under we company’s on release at website the press this available morning the The Investors tab. being is call recorded. This A call. be the dial-in will XX phone after hours available close for the of replay in The webcast be Relations also replay website. of company’s the XX the available section Investor for will days

Brian Officer. from follow comments overview call position. on Chief Q&A. you will Armand an and current We’ll then Financial today include I’d Harout We’ll today’s Chief remind with expectations. GlycoMimetics Business call financial provide start me Harout. Joining call Executive Semerjian, from the Officer; company’s Girard, are on will to of to statements call the open for Officer; Hahn, that based forward-looking Chief the today’s Brian like

or this regarding GlycoMimetics update are programs; Forward-looking position operations, about GMI-XXXX planned forward-looking call and commercialization interactions to, statements statements candidates, but or expectations Such company’s pipeline collaborations. and development, and potential and obligation no trials and from other studies may about limited our include, the statements or not product clinical management’s regulatory uproleselan, any potential preclinical as cash judgment well strategic data with or statements risks uncertainties. assumptions, as along represent of activities involve intention or submissions today revise undertakes to and future statement. as on

could the website. which please the company, GlycoMimetics affect that over turn refer filings factors on risk from available Harout. are SEC, call the the with now GlycoMimetics’ concerning the information SEC For I’ll to the to or

Harout Semerjian

our we the call good X Thank for our ago, In ahead. strategy and and year-end you, Shari, year outlook shared morning, everyone. weeks

and readiness a and our both advance designed on commercialization. uproleselan, with focus updates provided program, lead to regulatory activities, commercial our all towards have We GlycoMimetics

position data once XX is will AML. projected us registrational our the for to our to enrolled effort trigger Australia are is an Our data XXX regulatory line timing the highest in quickly overall submissions analysis, event and the in we total Europe, move U.S., relapsed/refractory trigger line top and readout. This a trial subsequent is in data the Phase from event Today, sites that survival III that the Canada updating confirming of the of readout and today top collecting priority patients ongoing achieved.

As continue track projections, our in current thereafter. reaching time. on we line our disclosure shortly III Phase overall now top data anticipate matures, trigger event to we events survival mid-XXXX, Based with data in real

this to with more Our provide milestone. timing plan updates even of is on precision the

be salvage standard action that confident complementary used highly an to with is to will a is ideal therapies chemotherapy. has uproleselan combination prove today. of We’re It and the differentiated that mechanism

bone be clinical extrinsic of will role in communities effort that uproleselan’s targeting recent have to of Several and extrinsic effort on focused entry. parallel, community resistance launched This for factors microenvironment, comprehensive the research its of uproleselan In on potential treatment uproleselan key to prepare educating the AML regimen is currently on and and central scientific we in marrow cytogenetically factors education anticipated targeting of a the is note. in molecularly, agnostic. patients by drug The treating leaders AML taking are opinion Importantly, the perspectives role shared medical chemoresistance. programs. market communications

these viewed of now Some can materials website. our on be

by setting being is also know, you evaluated the the Institute. National uproleselan Cancer in As frontline AML

trial last Phase II/III November the recall this that II patient of well. portion enrolled will last Phase as You its

When us, planned regulatory with the data As II Under for of access purposes. will interim in NCI’s the the diagnosed anticipation event-free data a in the terms issue the analysis the analysis. of to is protocol, its NCI enrollment survival has Phase per of outcome the suspended of the we partnership communicated newly will NCI’s to setting our NCI, be we release. press able

In uproleselan’s evaluating potential addition registrational-stage additional in to have X indications. currently we trials programs, investigator-sponsored several advancing

these a investigators cell we disease. collaborate to matures. to meetings principal We theses. X of GMI-XXXX pleased toxicity for that I comment GMI-XXXX trials. continue have the like no concerns. medical the also completed. IND-enabling GMI-XXXX IND-enabling share I’m program the safety standard sickle concerns the showed to XX-day studies goal GMI-XXXX on would demonstrated of findings with now from made battery of in as progress has no We safety studies in report data different been GLP of with at publishing The major their

And there development; institutional our development to turn an future indication. of in we on have it flexibility invest the of in support our We streamlining represents commercially expertise file the headcount on incorporated journey, assets the positioning its evaluate Brian, year remain By into our the in pipeline remind patients that to our have acute with of now product provide the financial declared in were milestone track the lead have Filing IND We greater who we will pipeline half of cell that created clinical the late-stage the on to our reductions galectin-X cell GMI-XXXX I’ll drug efforts. disease that we reduced uproleselan’s efforts. Consistent you to as in largely departments, opportunities. With rich the GMP orally advance be week, received our organization. remains pre-IND candidate a stage by basic is and first-in-human in guidance the last treatment research clinic; therapy program, acute FDA-approved now a approximately XX%. this in transformation FDA over IND and we vaso-occlusive of third we about The I with of asset, a to now focused early use that our manufactured first while GMI-XXXX, bioavailable efforts the our no helped uproleselan VOC as now appreciate produce for to overview lead research, sickle knowledge compound chemistry support enter accelerate to everyone an and activities patients results. the for have commercialization partnerships. colleagues crisis We in sickle will to from to important for submission. today. key study. stability this maintained to greatly

Brian Hahn

Harout. you, Thank

to individuals batches. The AML partially administrative expenses ended had offset expenses our company’s same decrease March period quarter in million and by and ended December primarily fees. the As in $X.X back turn million to uproleselan clinical validation XXXX, expenses XXXX. clinical were XX, of due of as The with XXXX, million to trial the $XX.X due like for March and to XX, for uproleselan The increased of global enrollment cash of compared Phase trial to to quarter compared equivalents first expenses to relapsed/refractory the start-up $X.X manufacturing as higher $X.X III related company’s primarily patent and in Harout. for of call general to development XX, ongoing as for for uproleselan costs as The XXXX, decreased ended lower $XX.X XXXX. commercialization cash patient GlycoMimetics as development expenses XX, million $XX.X March for compared XXXX, the November million I’d higher research now XXXX. to to quarter and was million the decreased

Harout Semerjian

Brian. you, Thank

by durable cell by -- the to uproleselan MRD chemoresistance This patients stem conclude, remissions; approach negativity; to rates and more novel therapies. AML is we a outcomes bridging of transform not has deeper, potential higher by successful a to in believe addressed patients to more AML transplant. So existing achieving

other and ligands well inflammatory I’d and AML. GlycoMimetics disease at However, glycans are important that play cancer, to fibrosis. extends the stress The beyond roles to like E-selectin opportunity now known here in

the its I’d have Over generated the like full a breakthroughs. clinical potential. now years, therapeutic now for Operator? serve to positioned future foundation open demonstrate pipeline of to the active of is line Q&A. to as time The we drugs

Operator

[Operator Wainwright. White question the from Instructions] H.C. Your first line with of Ed comes

Ed White

on as you’re questions your update So us such timing just data, CMC you thoughts to what work on the start. following doing Could give perhaps top a an upro line Officer, the to couple on And strategy. your on submission of also give you wanted hiring idea a now, thoughts et And market. Commercial the right cetera? us Chief just sales maybe initial your the to with I of get of some can

Harout Semerjian

your questions. Thanks, for Ed,

we the forward. relapsed/refractory great more that we sure us thinking designation, this, the be data that that will So want happens, and able so now to of true that the matures that data. that population event matures, innovation breakthrough make weeks, everyone, for anyway, once of I’m ongoing very line If the we way have and communicate have fit to to so segment than therapy opportunity positive, discussions as part for sure fast. trigger remind as ourselves years, bring Ed, that means, patients prepare to any our a once we top for is that we’re within -- we’re is a with And agency for a few of is segment data that motivated XX that had just chemotherapy, not patient move forward to everybody have

proactively, planning back sure we’re by time using now, on we’re to end. our time make that, the So cutting from

been regarding a XX% that. the every deemed population and commercialization are the of from too fit chemotherapy, part talk year patients kind early in of diagnosed XX,XXX patient the every overall really of second who the hasn’t Now about the X,XXX to of for strategy is There which much strategy, -- of XX,XXX population, advances in relapsed/refractory is And perspective. your die this. think a of AML there from in But them with question are commercialization U.S. year. it’s that although patients the about

And lot going a lot Pharma So last that to not pent-up been demand area. a working really competitive for therapies there’s to out. this in the from unfortunately And of perspective, patients, people Rafael of was you the asset. A that market. imagine have bring tried them in can has ramp it’s of be not that given --

more these shot to in a within excited therapy relapse/refractory, if patients. start line as X,XXX very we’re It’s front So to new take the have well. for of the a you bringing

educated quite sure of quite of novel because making the is So action mechanism novel. extrinsic This is we’re are complementary. on from the chemoresistance now mechanism people and that action

time that So from perspective. we’ll use that

So high it’s education to I then that unmet first question. hope I focus and your ramp on really answered need. up medical really

Ed White

for question Brian. a maybe And Yes.

mostly you You in week. impact forward reduced on thoughts we last Is thinking runway. your XX% of your the XXXX? had us headcount also should about cash expenses operating can R&D? the going if be give And for How mentioned

Brian Hahn

Thanks, Ed.

a reduction guided our continue is the several from I The $XX think spend for on million previously, we’ll be we But resources. million laser-focused headcount reduction. spend where XXXX. we to about to

So those With money. our us reviewing that, slight reduction of XXXX. sure into say that gets would third I make cash spend. are maybe current some And to hand spending actually constantly quarter where in XXXX, a the we of on

Operator

Peaker Boris Cowen. of line the from comes with question next Your

Boris Peaker

the time Great. My in on line comment you the you from study? the think when II of the required, of threshold we’ll know first part? is component. on question the data the commence study. NCI second II And Do what’s Phase is, part you Phase to the the Could order kind what get

Harout Semerjian

before Armand. pass I’ll I it Sure, -- Maybe to Boris.

We’re ongoing very We’ve and excited Armand that about NCI that is having the with dialogue partnership. effort. been leading

So this, comment on want Armand? you to do

Armand Girard

Yes. Boris.

don’t So We details when analysis survival. conducted. the going to II Phase specifics that of the regards component is is with to It’s be event-free event-based. get

better act then outcome a study way time there’s is done, they data will X which year. our ratio achieves The to arm And have them. confidentially that they that if is is analysis ratio decision classify they Phase to would transfer the if of November will to regards the as into to promising to With for they’ve combination When us. would the completed last hazard us when the the trial what of the the points, upro So the X X.XXX, data mature X.XX, the the they’re And also III. is for also on. -- regulatory then communicate we support waiting to suspended submissions. analysis. will as signal and of overwhelming hazard is be would trying than that’s a Then and we actual conduct runs enrollment at better they the basically proceed period they’re the show efficacy. plus What of that X than enrollment

Boris Peaker

this see sounds estimate timing it have should like you point. data of we don’t But at an when that of

Harout Semerjian

but NCI versions, has that, more We’ve it than not The Yes. be rumors else. different would communicated anything heard Boris.

from us. them. read rather Armand of I ready, As be once communication be guesstimating official they’re to EFS said, that typical think communicate more would an will But than having they primary faster trial OS. again, endpoint it should mean, than would that to theoretically

Operator

Your comes the Song question next from line Jefferies. from Roger of

Roger Song

Great.

also the So first about one, Phase III. upro

event the rates? you kind drives triggering? event can for expectation? far? Like midyear can with current or on Also, your drop-out line projection the in comment So so Is previous the on you enrollment rate that event this what comment or just of

Harout Semerjian

Roger. Thanks, Yes.

I things you November in the we November started know, trial as ended So that the in the mean, ‘XX. have disclosed, ‘XX -- start and

So is enrolled event-driven. over we And have a period, patients. study XXX X-year survival, overall an the

drives What estimated is trigger have we a events faster I’ve we’re you last mentioned longer. If times like, be That’s patient event a a what, living XX is it November before, more trigger slower faster of situation out towards there, is, rather it a is I’d more pressure the think we at event events, time number, I means couple the way period. XXXX. enrolled is where prespecified data patients we line. are events. have So and what of it slower XX we look happen. slower that months have middle drives events. trigger. it the trigger but that If The XXXX, once would data on The have about And we events, seeing is as getting midyear there months, at the have Obviously, faster in events. XXXX, puts

into you you statistical caveats is, don’t a it’s the arm towards several know indicating events, that’s obviously, with model. of right at them a we data. now, put we’ve those have we anything it And the access other they’re run driving of But to on, point Now XXXX. this kind this don’t pool than when times what’s midyear have which

Roger Song

Got it. That’s helpful.

Okay.

would like and reduction, early for inhibitors? regarding what development of the So XXXX -- plan and pipeline, the the the stage the pipeline kind with couple of be other recent galectin-X early

Harout Semerjian

Yes.

at early what discovery the later development reiterate part, have and headcount of biotechs the it. we reduction be part been of Because impact research, time. organization. fact, medical over looking predominantly the to enhanced affairs any typically, has the have doesn’t And part stage lot just in that’s asset, or Roger. It The the on So those, to lead in said. in a will one we’re

asset. lead one have We

that XXXX clinic. have We was in

be asset Now XXXX, bioavailable And we’re filing X of XXXX. galectin-X, clinic. have for an can we IND so where ago then that lead declared ready orally weeks we the

and and and point, to this fact in-house, this a what commercialization And always development, keeping we the to other medical institutional of assets towards to because wanted So out point, glycobiology back really chemistry at And go we that institutional We’ve paused, advance believe as can we we is that’s already early really that that knowledge advance. more Roger. additional the kind But education for we pivoting affairs, meaning development to the we’re knowledge ramp department differentiating because last we’re in up uproleselan keep of the activities. focus, really work have that players we of whole X really XX honed what factor do, years. over is do the versus us there.

very we about So been go about how it. we’ve doing deliberate

biotechs you assets XX, have with to in these have But days. the until that we’re maturity we next we uproleselan. believe XX data advance know, at. we a we’re over And position especially choices, As already have looking where team X can them months the make

Roger Song

bulk the of Yes, still Got glad the you it. see keep helpful. That’s to Yes. pipeline.

Okay.

a just last one. quick maybe So

cash guidance, said study, terms this studies In the for burn IND-enabling and the last pivotal rate time, runway of and covered upro that you CMC remember I XXXX.

runway seeking that’s mostly XXXX the confirm, to guidance, waiting Not included for of current -- for right? in partnership. Phase cash just kind want Just your I

Harout Semerjian

Yes. Correct.

filing bring a tackle. want is believe safe who the people partnerships, more in notice We course, also important we very doing we’re patients with of -- of advancing sickle then, and And cell for can that That an unmet funding like-minded really proceed discussions. not but be crisis what to need talking believe, expertise is like to partnership to that be that medical the who Roger, XXXX, humans vaso-occlusive about getting when we we’re going it’s IND and to open the So can IND. milestone. trial, of us, just will remains a clinical the high in very

the that filing XXXX. runway for is cash the this in point IND yes, not at So beyond

Operator

question the Zegbeh next comes with Jallah ROTH from Your of Partners. line Capital

Zegbeh Jallah

the probably you a one about first just I in a one we reduction just of follow-up think you’re Was is that had XXXX. partnership. The know for just had the about to kind thinking there how team. last your just I curious

And anticipate end? on you you on additional perhaps was would commercial more so use up your it that upro? that the if towards cash accelerating or maintaining towards with looking back could for wondering, I for plans think coming was capital or the upfront something And do upfront, you team,

Harout Semerjian

Thanks, Yes. Zegbeh.

flexible mean, we’re from to a different partnerships, open ideas. I partnership So perspective,

flexible want vaso-occlusive we as As is long -- where not that address crisis cell sickle we’re thinking patients. of to on really the the

the that’s really like-minded it. Is upfront, have also the Obviously, cash Obviously, back this going passionately will important. is Is a also it be so We’re end can value forth. have to more partner to and want cashing about but And and would upfront? open funding to afterwards? on we of who feel and as on important, the so where we’re So kind to we give advance. direction be it.

of point. you the So it we meet a partner terms many comment? And vision you evaluate believe a mean, starting of... as as want they be that we idea these will Armand, do credible is has to first carefully I mature. to But in

Armand Girard

while ended. typically asset; value-creating product those uproleselan. And Z, and right stability it of expected IND significant derisking this clean it, deals is is it the to a demonstrating more with on the asset the are always ready the would important having of an say off having X,XXX-fold stage bat, also making an preclinical back tox for clinic. and GlycoMimetics. it, profile, more So But And we event along is a was drug a the potent compound If showing and than I the in go matters. fact;

go, we to deal should this And think to been also So in IND that that valuable FDA very a very prospective is be think the interest always position. into to and the we’re having valuable strong proceed, but translate program. safe But in us, partner. There going has a terms. to we from

Zegbeh Jallah

And from it about delivery different though proof really provides concept. think upro. different interesting. just wanted just think Even ask to have that’s I using you rivipansel? now sufficient a the of I it’s seen a program, even data, And method. you’re And is another that question I But

try diagnosed for would the could remind you you I the the EFS of on helpful of it newly estimate relapsed/refractory folks we in when in OS of As the terms think provide setting standard in we agents or data, setting. what terms be care to see maybe thought to in should

Harout Semerjian

Do the you to want setting? address newly diagnosed

Armand Girard

Yes.

question, the trying be? at? what to to Z, regards trying we’re get to you’re was what with So Is what is expectation just the that

Zegbeh Jallah

Yes.

to is going standard you? agents be And care beyond So the get what looking guess, for actually that. then, I we’ll anything

Armand Girard

Yes.

setting something So frontline with best around X on months, expect the to case. regards you’d EFS,

is of we’re something to in so And what XX-plus.. trying show excess

Harout Semerjian

stable a bit hovering as XX%. around advances been like transplant that rates Z, that around that has XX%-ish. more relapsed/refractory, X the in months many higher Lately years to quite the transplantation overall with some XX%, on point, for then with survival many, you inched And has know, techniques,

MRD MRD that’s getting that’s II for as best a indicator seen do publications in with us, several the recently, know, a patients Phase of would deeper as remission been XX% data. So our there’s how the negativity, We’ve that is a say to area of focus kind an indicator. post-transplantation. we for And negativity patients

for to but not trying That’s with would our by pleased longer negativity, that hopefully has So remissions by a by all we’re survival, more translate III into obviously X we’re those really months beat overall transplant, Phase deeper and how, overall been transplantation. that bridging getting directions. And to patients censored survival. MRD why

that’s in so beat. the that we’re to to what’s can plan, what So that for trying waiting see data that’s we’re come we happening. eagerly But

Armand Girard

And I either. not Z, would trial for NCI the transplant that is add, censored

transplant So is good a outcome us. for

or not occurs. if we a with a either That’s that’s that, at to EFS, they that’s censored they do, get So But to going relapse good failure get hope response, death. be outcome. the transplanted, that which the time

Zegbeh Jallah

color Really question. one to combo Was non-censoring. try additional around as is see really help that the a last could just estimate actually good And data. people when the the in we then here

I partnerships. in then these folks to of on And last wondering you with you of Are an think well? is you’ve to Again, on any to you for so also plans going program. there? into just interested effort. know move will where Are was Or are what I as from partner of in are just update put capital I that, Again, the GMI-XXXX. I this understanding the one maybe coming be mentioned part the your first just planning kind program? just galectin-X plans think you additional are that is additional potential kind this considering forward? partnering cash any

Harout Semerjian

question me address question. your then Armand to let weigh first, your and on first ask I’ll So last

the have have CXCRX XXXX, the -- E-selectin Z, ago, that weeks we the when that we on given announced component. I Phase the on Duke both seen trial, obviously, I, mean, and closed X we the we’ve So activity

an it an -- for well, comment. And as accelerating declared X we course, we’re down it to the that, we also, honest. galectin-X is gotten announced So we’re a more into very it’s uproleselan we now of strategic choices, to but point on and runway, closed towards We’ve we ago, IND. that make for that then got next kind Armand are the I it we before our where doubling And Because options of a of hand think weeks we got phase, cash and that’s bioavailable trial. on have where pleased why ready be some to now we’re really XXXX, with for XXXX, orally to to dose.

us over color, So if maybe, some give Armand, there? you any, can

Armand Girard

I oral fibrosis that having is fibrosis, Listen, cardiac in wanted data to think plays those is a Galectin-X strong an cancer what arenas. an significant like And we as like to No. diseases compound compound. well some very having the us. a significant as settings. oral get role NASH, was But breakthrough in Yes. idiopathic pulmonary for

on goal in get And discussion to a is Z. research option the mode we a with activities partnering to a ongoing full of We are GMI-XXXX. point agreement and And having are partner. as speak, those collaboration

Operator

there As in Instructions] the I queue, would Semerjian. more questions Mr. are to to like [Operator no turn the back microphone

Harout Semerjian

I Thank we’re in of the person, for be conferences York you. Miami, And different attention. would Conference New and Investment thank in City. and at like May Global H.C. to Conference Wainwright’s time you Healthcare Jefferies in your all to In planning in at June, X investment

that progress our updating have and thank day. call, and you look outlook. can to so you be we forward scheduled and on great So Once for our again, a joining to one-on-ones much our

Operator

call. conference Thank a for [participation], this day. today’s have and wonderful Ladies concludes you gentlemen, and

may You all disconnect.

GlycoMimetics (GLYC) 30 Apr 222022 Q1 Earnings call transcript